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To obtain FDA registration and certification in the USA, medical devices must meet several key requirements:

1. Device Classification:

   • 510(k) Premarket Notification: For devices that are substantially equivalent to existing ones. Requires proving equivalence to a predicate device already on the market.
   • Premarket Approval (PMA): For high-risk devices needing comprehensive clinical data to demonstrate safety and effectiveness.

2. Pre-market Submission:

   • 510(k) Submission: Includes device description, intended use, and substantial equivalence data.
   • PMA Submission: Requires detailed clinical studies, data on device performance, and evidence supporting safety and efficacy.

3. Quality System Regulations (QSR):

   • Compliance with FDA’s Quality System Regulations (QSR) is necessary. This involves establishing and maintaining a quality management system for manufacturing and testing devices.

4. Labeling Requirements:

   • Devices must meet FDA labeling requirements, including clear instructions for use, warnings, and device specifications.

5. Registration and Listing:

   • Facilities must register with the FDA and list their devices. This involves submitting the necessary forms and paying applicable fees.

6. Compliance with FDA Standards:

   • Devices must adhere to relevant FDA standards and guidelines, which can vary based on device type and risk class.

7. Post-market Surveillance:

   • Ongoing reporting of adverse events and device performance is required once the device is on the market.

Meeting these requirements ensures that a device is approved for marketing and distribution in the U.S.

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